Depressive SymptomsNCT04951193

Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents

A study testing Behavioral Activation Therapy app and Treatment as Usual in people with Depressive Symptoms and Depression, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 20 yearsHealthy volunteers can take part
Conditions the study is for: Depressive Symptoms, Depression, Adolescent Behavior
What is being tested?: Behavioral Activation Therapy app and Treatment as Usual
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2021to 21 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 20 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

age 16-20
vaped nicotine on ≥20 days out of the last 30
elevated depressive symptoms, defined as a score of ≥10 on Patient Health Questionnaire-8 (PHQ-8) during preliminary screening and the Adolescent Patient Health Questionnaire-9 (PHQ-9A) at final eligibility
currently own an iOS or Android smartphone
report willingness to utilize an app for quitting vaping nicotine (response of "yes" on yes/no item)
have a valid e-mail address that is checked regularly or regular access to text messages (for follow-up assessments)
ability to read the consent form
has been seen (in person or remotely) by a primary care physician within the last year

Who cannot join

smoked cigarettes or used other tobacco products on ≥9 days out of the last 30
severe visual impairment
currently receiving treatment for vaping or tobacco use
current suicidal ideation, defined as a response ≥1 on item nine of the PHQ-9A or ≥2 on item 9 of the BDI-II
household member currently enrolled in the study
inability to read the consent form

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Development and Evaluation of a Brief Behavioral Activation Mobile Application for Nicotine Vaping Cessation Among Adolescent Primary Care Patients

The purpose of this study is to evaluate a mobile application (app) called "Goal2QuitVaping" to help adolescents quit vaping nicotine. Goal2QuitVaping was developed by our research team to assist with quitting vaping. Participants will be randomly assigned to either download the mobile app, "Goal2QuitVaping", or not. If provided with Goal2QuitVaping, participants will be asked to use the app regularly, at least once per day, throughout the study duration. Participants will be asked to complete electronic questionnaire measures throughout the study period. Participation in this study will take about 4 weeks.

Conditions: Depressive Symptoms, Depression, Adolescent Behavior
Being tested: Behavioral Activation Therapy app, Treatment as Usual
Medical subject headings: Depression, Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Behavioral Activation Therapy appBehavioural
Goal2QuitVaping focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. Participants will be asked to complete questionnaire measures weekly for 4 weeks following study enrollment.
Treatment as UsualBehavioural
Participants will be provided educational material about quitting vaping nicotine with the suggestion to discuss questions with their PCP. Participants will be asked to complete questionnaire measures weekly for 4 weeks following study enrollment.

Study groups in NCT04951193
Study group	Role	What they receive
Goal2QuitVaping	Experimental	Participants in the Goal2QuitVaping group will be asked to download the Goal2QuitVaping app to their smartphone. Goal2QuitVaping focuses on mood management as well as on quitting vaping nicotine. Participants will be asked to use Goal2QuitVaping regularly, at least once per day, for the study duration. Participants will also be asked to complete questionnaires weekly for 4 weeks. Receives: Behavioral: Behavioral Activation Therapy app
Treatment as Usual	Other	Participants in the treatment as usual group will be provided with educational material about quitting vaping nicotine and it will be suggested that they discuss any questions about mood management and about quitting vaping with their primary care provider. The educational material is from the National Cancer Institute's SmokeFree Teen website and includes information on recognizing reasons for quitting vaping, avoiding dual use of e-cigarettes and other tobacco products, setting a quit date, understanding triggers, and accessing social support. Receives: Behavioral: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Score of Depressive Symptoms
Patients will self report depressive symptoms weekly for 4 weeks via the Beck Depression Inventory-II. The range of scores possible are 0 - 63, where lower scores are indicative of lower symptoms of depression. This outcome will measure change from baseline at week 4.
Measured: Up to 4 weeks
Average Vapes Per Day at Week 4
Assessed using the Timeline Followback during each weekly assessment. Average vapes per day at week 4.
Measured: Week 4
E-cigarette Dependence
Assessed at baseline via the 10-item Penn State Electronic Cigarette Dependence Index (ECDI). Change from baseline at week 4. The scores range from 0-20 with 0-3= not dependent, 4-8 low dependence, 9-12 medium dependence, 13+ = high dependence.
Measured: Up to 4 weeks
Number/Duration of Quit Attempts
Assessed during the Timeline Followback. Total number of quit attempts across all 4 weeks
Measured: Across all 4 weeks
7-day Point Prevalence Abstinence
Assessed during the Timeline Followback. At any point during the study across all 4 weeks.
Measured: At any point during the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202121 Jun 2023

First posted6 Jul 2021
Study start1 Jun 2021
Primary completion24 May 2023
Study completion21 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Depressive SymptomsStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04951193
Sponsor's protocol ID: 00108733
Other IDs: 1R41DA053856-01
Status last verified: Jul 2024
First submitted: 25 Jun 2021
Last updated: 21 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depressive Symptoms trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Evaluation of a Brief Behavioral Activation Mobile Application for Nicotine Vaping Cessation Among Adolescent Primary Care Patients
ClinicalTrials.gov ID: NCT04951193
Acronym / sponsor ID: 00108733
Conditions: Depressive Symptoms, Depression, Adolescent Behavior
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
Study start: 1 Jun 2021 (actual)
Primary completion: 24 May 2023 (actual)
Study completion: 21 Jun 2023 (actual)
First posted: 6 Jul 2021 (actual)
Results: Posted 7 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Goal2QuitVaping	Experimental	Behavioral: Behavioral Activation Therapy appParticipants in the Goal2QuitVaping group will be asked to download the Goal2QuitVaping app to their smartphone. Goal2QuitVaping focuses on mood management as well as on quitting vaping nicotine. Participants will be asked to use Goal2QuitVaping regularly, at least once per day, for the study duration. Participants will also be asked to complete questionnaires weekly for 4 weeks.
Treatment as Usual	Other	Behavioral: Treatment as UsualParticipants in the treatment as usual group will be provided with educational material about quitting vaping nicotine and it will be suggested that they discuss any questions about mood management and about quitting vaping with their primary care provider. The educational material is from the National Cancer Institute's SmokeFree Teen website and includes information on recognizing reasons for quitting vaping, avoiding dual use of e-cigarettes and other tobacco products, setting a quit date, understanding triggers, and accessing social support.

Who may qualify

Ages: 16 to 20 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

age 16-20
vaped nicotine on ≥20 days out of the last 30
elevated depressive symptoms, defined as a score of ≥10 on Patient Health Questionnaire-8 (PHQ-8) during preliminary screening and the Adolescent Patient Health Questionnaire-9 (PHQ-9A) at final eligibility
currently own an iOS or Android smartphone
report willingness to utilize an app for quitting vaping nicotine (response of "yes" on yes/no item)

Key exclusion criteria (6 listed)

smoked cigarettes or used other tobacco products on ≥9 days out of the last 30
severe visual impairment
currently receiving treatment for vaping or tobacco use
current suicidal ideation, defined as a response ≥1 on item nine of the PHQ-9A or ≥2 on item 9 of the BDI-II
household member currently enrolled in the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Behavioral Activation Therapy appGoal2QuitVaping focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. Participants will be asked to complete questionnaire measures weekly for 4 weeks following study enrollment.	Behavioural	Goal2QuitVaping
Treatment as UsualParticipants will be provided educational material about quitting vaping nicotine with the suggestion to discuss questions with their PCP. Participants will be asked to complete questionnaire measures weekly for 4 weeks following study enrollment.	Behavioural	Treatment as Usual

Primary outcome

Mean Score of Depressive Symptoms
Time frame: Up to 4 weeks
Patients will self report depressive symptoms weekly for 4 weeks via the Beck Depression Inventory-II. The range of scores possible are 0 - 63, where lower scores are indicative of lower symptoms of depression. This outcome will measure change from baseline at week 4.
Average Vapes Per Day at Week 4
Time frame: Week 4
Assessed using the Timeline Followback during each weekly assessment. Average vapes per day at week 4.
E-cigarette Dependence
Time frame: Up to 4 weeks
Assessed at baseline via the 10-item Penn State Electronic Cigarette Dependence Index (ECDI). Change from baseline at week 4. The scores range from 0-20 with 0-3= not dependent, 4-8 low dependence, 9-12 medium dependence, 13+ = high dependence.
Number/Duration of Quit Attempts
Time frame: Across all 4 weeks
Assessed during the Timeline Followback. Total number of quit attempts across all 4 weeks
7-day Point Prevalence Abstinence
Time frame: At any point during the study
Assessed during the Timeline Followback. At any point during the study across all 4 weeks.

Results and safety

Results posted to the registry on 7 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Goal2QuitVaping	56	49
Treatment as Usual	50	45

Primary outcome: Mean Score of Depressive Symptoms

Time frame: Up to 4 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Goal2QuitVaping n = 50	Treatment as Usual n = 49
Value	-9.50 (9.54)	-8.30 (9.72)

Primary outcome: Average Vapes Per Day at Week 4

Time frame: Week 4. Mean (Standard Deviation). Unit: vapes per day

Measure	Goal2QuitVaping n = 50	Treatment as Usual n = 49
Value	9.42 (16.11)	10.17 (11.89)

Primary outcome: E-cigarette Dependence

Time frame: Up to 4 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Goal2QuitVaping n = 50	Treatment as Usual n = 49
Value	-2.19 (3.30)	-2.38 (2.86)

Primary outcome: Number/Duration of Quit Attempts

Time frame: Across all 4 weeks. Mean (Standard Deviation). Unit: number of quit attempts

Measure	Goal2QuitVaping n = 50	Treatment as Usual n = 49
Value	5.00 (4.35)	4.00 (4.11)

Adverse events

Time frame: 4 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Goal2QuitVaping	0 of 56 (0%)	0 of 56 (0%)	0 of 56
Treatment as Usual	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Depressive Symptoms

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Active, not recruiting
Improving Mood for Adolescents Through Teaming With End-Users in Routine Care (The iMATTER Project)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer Dahne, PhD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Activation Therapy app and Treatment as Usual in people with Depressive Symptoms and Depression, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Score of Depressive Symptoms (time frame: Up to 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04951193.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.